Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults

NCT07304518 | Recruiting Phase 2

• 1 other identifier: BT-PRT-064-201
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about the efficacy and safety of PRT-064040 Nasal Spray versus placebo in the acute treatment of moderate or severe migraine.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Freedom From Pain at 2 Hours Post-dose

  2 hours post-dose

• Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose

  2 hours post-dose

Secondary Outcomes (18)

• Percentage of Participants With Pain Relief at 15 Minutes Post-dose

  15 minutes post-dose

• Percentage of Participants With Pain Relief at 30 Minutes Post-dose

  30 minutes post-dose

• Percentage of Participants With Pain Relief at 60 Minutes Post-dose

  60 minutes post-dose

• Percentage of Participants With Pain Relief at 2 Hours Post-dose

  2 hours post-dose

• Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose

  2 hours post-dose

Study Arms (4)

PRT-064040 nasal spray (dose 1)

EXPERIMENTAL

Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 1) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.

Drug: PRT-064040 nasal spray

PRT-064040 nasal spray (dose 2)

EXPERIMENTAL

Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 2) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.

Drug: PRT-064040 nasal spray

PRT-064040 nasal spray (dose 3)

EXPERIMENTAL

Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 3) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.

Drug: PRT-064040 nasal spray

Placebo

EXPERIMENTAL

Participants administered a single intranasal dose of placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.

Drug: Placebo

Interventions

PRT-064040 nasal spray DRUG

A single dose of PRT-064040 nasal spray

PRT-064040 nasal spray (dose 1); PRT-064040 nasal spray (dose 2); PRT-064040 nasal spray (dose 3)

Placebo DRUG

A single dose of placebo matched to PRT-064040 nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged 18-75 years (inclusive);
• BMI \< 35 kg/m²;
• Participant has at least 1-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition;
• Age at first migraine onset \< 50 years;
• Migraine attacks, on average, lasting about 4-72 hours if untreated or treatment-resistant;
• attacks of moderate to severe intensity per month within the last 3 months；
• Less than 15 days with headache (migraine or non-migraine) per month within the last 3 months；
• Participants on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change until the EOT visit;
• Patients diagnosed with chronic migraine who, owing to stable preventive therapy, have \< 15 headache days and 2-8 attacks of moderate to severe intensity per month in the 3 months before screening, and who meet all other entry criteria, may be enrolled;
• Able to comprehend and complete study questionnaires with electronic patient-reported outcome (e-PRO) application.

You may not qualify if:

• Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine.
• Participant with evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cardiometabolic disease, or prior history thereof, including:
• Ischemic heart disease, coronary vasospasm, or cerebral ischemia diagnosed within 6 months before screening;
• Previous stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, cardiac surgery, or percutaneous coronary intervention;
• Abnormal 12-lead ECG at screening;
• Poorly controlled diabetes mellitus or hypertension;
• Poorly controlled or severe peripheral vascular disease.
• Participant with any nasal structural abnormality, mucosal lesion, or disorder that could interfere with intranasal drug absorption.
• Participant with dysgeusia, hypogeusia, or related taste disorders.
• Participant with acute or chronic pain syndromes, or any other pain that in the investigator's opinion could confound study assessments.
• Participant with history of regular use of ergotamine or triptans ≥ 10 days per month for ≥ 3 months; or regular use of non-narcotic analgesics (e.g., acetaminophen, NSAIDs, gabapentin) ≥ 15 days per month for ≥ 3 months.
• Clinically relevant abnormal findings in hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or HIV antibody tests at screening.
• Participant with history of alcohol or drug abuse within 1 year before screening, or positive urine drug screen at screening.
• Pregnant or lactating women, or positive pregnancy test at screening.
• Participant with known hypersensitivity to the investigational product or any of its excipients, or history of significant allergic reactions.

Sponsors & Collaborators

• Sichuan Purity Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

The First Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ke Yao

CONTACT

86-028-60830544; ke.yao@btyy.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 26, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)